510(k) K101508 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
| Applicant | Ion Beam Applications S.A., Philadelphia PA, US |
| Decision | Substantially Equivalent, Aug 6, 2010 |
| Received | Jun 1, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101508
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2021 | Ion Beam Applications S.A. Proteus 235-Proton Therapy System Open, Classified |
LHN | None listed |
| Jun 20, 2018 | Ion Beam Applications S.A. Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2
Product Usage:
A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions suscept Terminated |
LHN | None listed |
| Jan 26, 2018 | Ion Beam Applications S.A. Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Terminated |
LHN | None listed |
| Nov 17, 2017 | Ion Beam Applications S.A. Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by Terminated |
LHN | None listed |
| Oct 17, 2017 | Ion Beam Applications S.A. Proteus 235, graphite block 8 Terminated |
LHN | None listed |
| Mar 23, 2017 | Ion Beam Applications S.A. Proteus 235 Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.